Esophageal Cooling During Ablation for Atrial Fibrillation

(eCool-US Trial)

Not currently recruiting at 10 trial locations

Overseen By David Callans, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Advanced Cooling Therapy LLC, d/b/a Attune Medical

Disqualifiers: Inability to consent, Age <18 or >85, Recent ablation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Day 0

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device that cools the esophagus (the tube connecting the mouth to the stomach) during an ablation procedure for atrial fibrillation (AF). AF is a heart rhythm issue that can lead to serious problems like heart failure. The trial aims to determine if cooling the esophagus prevents injury more effectively than standard temperature monitoring during the procedure. Participants will receive either the cooling device (ensoETM, Esophageal Cooling Device) or the standard temperature probe through random assignment. The trial seeks participants with AF scheduled for ablation under general anesthesia. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance the safety of heart procedures.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this esophageal cooling device is safe for use during AF ablation?

Research has shown that the ensoETM esophageal cooling device is safe for humans. Studies have found that using this device during certain heart procedures can significantly lower the risk of heat damage to the esophagus. For example, one study found an 83.4% reduction in such injuries when the ensoETM was used. Protecting the esophagus is crucial to prevent serious health problems.

The FDA has approved the ensoETM device, confirming its safety for its intended use. It helps manage body temperature and is specifically designed to protect the esophagus during heart procedures. So far, these studies have reported no major safety issues, making it a promising tool for reducing risk during treatments for atrial fibrillation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about esophageal cooling during ablation for atrial fibrillation because it offers a novel way to protect the esophagus from heat damage during the procedure. Unlike standard treatments that only monitor esophageal temperature, the ensoETM cooling device actively cools the esophagus to 4 degrees Celsius, potentially reducing complications. This method could make ablation procedures safer and more effective by minimizing the risk of esophageal injury, a common concern with current standard care.

What evidence suggests that the esophageal cooling device is effective for reducing ablation-related esophageal injury during AF ablation?

Research has shown that using the ensoETM probe during a procedure to treat atrial fibrillation (AF) can greatly improve patient outcomes. In this trial, participants in the study group will receive the ensoETM probe, which studies have found increases the likelihood of being free from irregular heartbeats after one year. The probe also eliminates the risk of serious esophagus injuries, such as an abnormal connection between the heart and esophagus. This cooling technology protects the esophagus during the heart procedure, making the treatment safer and more successful. Participants in the control group will receive standard temperature monitoring, which is the current standard of care. Overall, the ensoETM probe offers a safer option compared to standard temperature monitoring during AF treatment. ^{1 2 3 4 5}

Who Is on the Research Team?

David Callans, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for AF patients suitable for ablation treatment under general anesthesia, as per guidelines. They must have already decided on this procedure and be waiting for it. It's not open to those who can't consent, can't follow up with endoscopy, are younger than 18 or older than 85, or have a history of upper GI tract bleeding or esophageal conditions that contraindicate instrumentation during ablation.

Inclusion Criteria

I am approved for and waiting for AF ablation treatment under general anesthesia.

Exclusion Criteria

I am unable to give consent for medical procedures.

You cannot have the follow-up endoscopy for any reason.

You have a history of bleeding in your upper digestive system or have conditions that make it unsafe to perform procedures in your esophagus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo AF ablation with either the esophageal cooling probe or standard temperature monitoring probe under general anesthesia

Day 0

1 visit (in-person)

Follow-up

Participants may have an optional endoscopy camera between 12-72 hours post-ablation to assess esophageal thermal damage

12-72 hours post-ablation

1 visit (in-person)

Long-term Follow-up

Participants are monitored for freedom from atrial arrhythmia and incidence of major adverse events at 3, 6, and 12 months post-ablation

12 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ensoETM. Esophageal cooling during AF ablation
• Esophageal temperature monitoring probe

Trial Overview The study compares the safety of two probes during AF ablation: a new cooling probe designed to protect the oesophagus from heat damage versus the standard temperature monitoring probe. Participants will be randomly assigned in equal chance to receive either the new cooling probe or standard care.

How Is the Trial Designed?

Group I: Study group Active Control 1 Intervention

Those randomized to the study group will receive the esophageal cooling device- the ensoETM probe, during AF ablation treatment, under general anaesthetic. The cooling device is set to 4 degrees Celsius during ablation of the left atrial posterior wall.

Group II: Control group Active Control 1 Intervention

Those randomized to the control group will receive standard of care, which is an esophageal temperature monitoring probe during their AF ablation procedure, under general anesthetic. The esophageal temperature probe is placed close to the level of ablation (the probe should be at the esophageal level where, opposite this, the ablation catheter is at, in the endocardial aspect of the posterior left atrium).

ensoETM. Esophageal cooling during AF ablation is already approved in European Union, United States for the following indications:

Approved in European Union as ensoETM for:

• Esophageal protection during atrial fibrillation ablation

Approved in United States as ensoETM for:

• Reducing the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures

Who Is Running the Clinical Trial?

Advanced Cooling Therapy LLC, d/b/a Attune Medical

Lead Sponsor

Advanced Cooling Therapy, Inc., d/b/a Attune Medical

Lead Sponsor

Trials

7

Recruited

270+

Kansas City Cardiac Arrhythmia Research LLC

Collaborator

Trials

1

Recruited

150+

Attune Medical

Collaborator

Trials

6

Recruited

690+

The Queen Elizabeth Hospital

Collaborator

Trials

45

Recruited

27,000+

Berry Consultants

Collaborator

Trials

16

Recruited

58,200+

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Trials

399

Recruited

1,004,000+

Royal Brompton & Harefield NHS Foundation Trust

Collaborator

Trials

236

Recruited

150,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Texas Cardiac Arrhythmia Research Foundation

Collaborator

Trials

40

Recruited

15,400+

Published Research Related to This Trial

In a study of 445 patients undergoing catheter ablation for atrial fibrillation, the use of a multi-sensor esophageal temperature probe significantly reduced the incidence of endoscopically detected esophageal lesions (EDEL) compared to a single-sensor probe, with EDEL rates of 6.8% versus 24.3% during cryoballoon ablation.

The multi-sensor probe also showed a lower incidence of EDEL in patients undergoing radiofrequency ablation (19.5% vs 32.8%), indicating that using this technology can enhance safety during AFib ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal luminal temperature monitoring using a multi-sensor probe lowers the risk of esophageal injury in cryo and radiofrequency catheter ablation for atrial fibrillation. Abdulsalam, NM., Sridhar, AM., Tregoning, DM., et al.[2023]

In a study of 100 patients undergoing atrial fibrillation ablation, the incidence of esophageal injuries was similar between two types of temperature probes used for monitoring, with 20% injuries in the multi-thermocouple group and 30% in the deflectable probe group.

Most esophageal lesions were mild to moderate and resolved with conservative treatment, indicating that while esophageal injuries can occur during the procedure, they are generally not severe and can be managed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidences of esophageal injury during esophageal temperature monitoring: a comparative study of a multi-thermocouple temperature probe and a deflectable temperature probe in atrial fibrillation ablation. Kuwahara, T., Takahashi, A., Takahashi, Y., et al.[2021]

In a meta-analysis of 4 non-randomized controlled trials involving 411 patients, esophageal temperature monitoring during radiofrequency ablation for atrial fibrillation did not significantly reduce the incidence of thermal esophageal injuries compared to no monitoring, with injury rates of 8.9% and 6.8%, respectively.

The study highlights the need for more rigorous research, including randomized controlled trials, to better understand the effectiveness of esophageal temperature monitoring in preventing thermal injuries during atrial fibrillation ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal Temperature Monitoring During Radiofrequency Ablation of Atrial Fibrillation: A Meta-Analysis. Koranne, K., Basu-Ray, I., Parikh, V., et al.[2020]

Active esophageal cooling during radiofrequency ablation for atrial fibrillation significantly reduces the risk of thermal injury to the esophagus, which can lead to life-threatening complications like atrioesophageal fistula.

This cooling technique not only enhances patient safety by minimizing esophageal damage but also improves procedural efficiency, leading to shorter procedure times, less postoperative pain, and higher rates of same-day patient discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active esophageal cooling during radiofrequency ablation of the left atrium: data review and update. Cooper, J., Joseph, C., Zagrodzky, J., et al.[2023]

In a study of 76 patients undergoing catheter ablation for atrial fibrillation, 50% received esophageal cooling during the procedure, but this method did not significantly reduce the incidence of esophageal thermal lesions (ETL).

While there was a non-significant trend indicating fewer severe lesions in the cooled group (13.5% vs. 29% in the non-cooled group), the overall results suggest that esophageal cooling may not be an effective strategy to prevent ETL during ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of esophageal cooling on esophageal injury during radiofrequency catheter ablation of atrial fibrillation. John, J., Garg, L., Orosey, M., et al.[2021]

In a study of 543 patients undergoing RF ablation for atrial fibrillation, the multi-sensor temperature probe detected higher intraluminal esophageal temperatures (≥ 39°C) in 75% of cases compared to 39% with the single-sensor probe, indicating better monitoring capability.

Despite the multi-sensor probe detecting more cases of elevated esophageal temperature, the severity of esophageal injuries was similar between the two groups, suggesting that while the multi-sensor probe is more sensitive, it may not provide a significant advantage in preventing severe injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-sensor esophageal temperature probe used during radiofrequency ablation for atrial fibrillation is associated with increased intraluminal temperature detection and increased risk of esophageal injury compared to single-sensor probe. Carroll, BJ., Contreras-Valdes, FM., Heist, EK., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10359433/

Improved 1-year outcomes after active cooling during left ... A clinically and statistically significant improvement in freedom from atrial arrhythmia at 1 year was found in patients treated with active esophageal cooling.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04577859

Esophageal Protection Study: A Multicenter Study In recent studies, it was shown that a more advanced type of esophageal probe (ensoETM) that cools the esophagus during ablation is better at protecting the ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/17434440.2024.2447809

Full article: Proactive esophageal cooling during ... Proactive esophageal cooling reduces injury to the esophagus during high power RF ablation, and utilizing this approach may result in increased success.

4. hospital.haemonetics.com hospital.haemonetics.com/esophageal-protection/ensoetm

ensoETM Statistically significant reduction in atrioesophageal fistula (AEF) rate from 0.146% with LET to 0% after adoption of the ensoETM® system; 0 AEFs identified in ...

5. academic.oup.com academic.oup.com/europace/article/25/5/euad099/7140577

Real-world results of oesophageal protection from a ... Recent randomized trial evidence suggests that active control of local temperature can significantly reduce thermal injury to the oesophagus during left atrial ...